This bill, known as the Medical Device Electronic Labeling Act, significantly amends the Federal Food, Drug, and Cosmetic Act to allow required labeling for medical devices , including in vitro diagnostic devices, to be made available exclusively through electronic means. This change aims to modernize how device information is disseminated, moving away from mandatory paper inserts for all devices. However, this electronic-only provision is subject to several crucial conditions designed to protect public health and ensure accessibility. Manufacturers opting for electronic labeling must ensure that the digital information complies with all applicable legal requirements and is easily accessible and user-friendly for intended users. Crucially, they must also provide an accessible mechanism for users to request the required labeling in paper form, which must then be supplied promptly and without any additional cost. The Secretary of Health and Human Services is granted authority to issue orders for additional labeling requirements or exceptions, particularly for devices used without provider supervision or where electronic labeling alone might not assure safety and effectiveness. Furthermore, the bill mandates that within two years of enactment, the Secretary of Health and Human Services, through the Commissioner of Food and Drugs, must initiate a public request for information. This process will gather stakeholder comments on how to further optimize the format, accessibility, and usability of electronic labeling for specific categories of devices, such as non-prescription devices not used in healthcare facilities or by professionals, and certain in vitro diagnostic devices. This ensures ongoing evaluation and improvement of electronic labeling practices.